Creating Submission Tasks

You perform the same steps to create tasks for submission templates and submission projects. You can create tasks in the Schedule page tab to assign to people who need to assemble documents for the submission project. For a submission template, each submission created from that template automatically inherits the task structure. For a submission project, you can create tasks regardless of whether you based that project on a template.

When Market Registration creates a schedule, it defines the Dossier Ready, Dossier Published, Dossier Submitted, Dossier Received, and Market Authorization milestones. In addition to creating tasks, you can edit these milestone tasks, such as changing some of them to mandatory or changing the estimated duration value.

See Project Management User's Guide: Working with Work Breakdown Structure (WBS) for complete details about this page.

Required access roles: Global User or Reader

Note: You must create tasks that are specific to Market Registration, such as Interactive Reviews, Review Questions, or Regulatory Milestones, in the appropriate places in the app. You cannot create a project task, such as a Task, Phase, Gate, or Milestone, then change it to a Market Registration type task.

Before you begin: View the Schedule page for a submission template or submission project. For a submission project, select Schedule in the navigation pane.
  1. Open the required submission template or submission project. See Opening a Submission Template or Opening a Submission.
  2. In the navigation pane, click Schedule.
  3. Select the top node in the list (the name of the submission template or submission project) or any existing task.
  4. Click Actions > Add Subtask Below, or for selected tasks only, click Actions > Insert Task Above.
  5. Enter these details:

    Field NameDescription
    Task TypeSelect the type of task to add to the submission project or template:

    • Task
    • Gate
    • Milestone
    • Phase
    • Regulatory Calendar
    • Regulatory Milestone
    • Interactive Review
    • Review Question

    Task NameEnter a name, or click the check box to use an automatically-generated name.
    DescriptionEnter details about the task.
    DurationEnter an integer in the box, and select Days or Hours from the list.
    Select PolicyThe default value is Project Task. If your company has created custom policies, select the needed one from the list.
    Task RequirementSelect Optional or Mandatory to indicate whether the task must be performed.

    For submission projects, most tasks are mandatory.

    Project RoleSelect a role from the list. Only people with that role can be assigned to the task.
    Constraint TypeSelect the type of constraint used to calculate estimated start and end dates for tasks.
    Constraint DateSelect the constraint date.
    CalendarClick to select a work calendar defined for your company.
    OwnerSelect the person responsible for the task.
    AssigneeSelect the person assigned to execute the task.
    Needs ReviewSelect Yes or No to indicate whether the task requires an internal review process. If you choose Yes, the app adds a route between the Review and Complete phases.
    Milestone Purpose

    Only shows for milestone tasks.

    		Select the purpose for this milestone from the list.
    Regulatory Milestone Purpose

    Only shows for regulatory milestone tasks.

    		Select the purpose for this milestone from the list.
    Pivot Milestone

    Only shows for regulatory milestone tasks.

    		 Select Yes or No to indicate whether escalation calendars can be added at this milestone.
    Connection Milestone

    Only shows for regulatory milestone tasks.

    		Select Yes or No to indicate whether local calendars can be added at this milestone.

  6. Click Done.

After creating tasks for a submission project (not a submission template), you need to assign them. When assigning the task to specific people, you can only choose people who have at least the Regulatory User role.

You can edit the Schedule page to choose a volume (a controlled folder) to contain the deliverable for each task. See Assigning a Task Deliverable to a Volume.